Comparative Study of Four- and Six-Strand Flexor Tendon Repair in Zone II

NCT07626190 | Completed

• 1 other identifier: No.48.ERC/FMU/2025-26/106
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Flexor tendon injuries in Zone 2 of the hand remain challenging because of the need to achieve optimal tendon healing while allowing early mobilization and minimizing complications such as rupture and adhesions. Various tendon repair techniques have been described, including four-strand and six-strand core suture methods. This study aims to compare the functional outcomes and complication rates between four-strand and six-strand flexor tendon repair techniques in patients with Zone 2 flexor tendon injuries.

Conditions

Hand Tendon Injury

Keywords

Zone 2 Flexor tendon injuries

Outcome Measures

Primary Outcomes (1)

• Functional Outcome according to Tang Criteria

  Functional outcome assessed using the Tang classification (Excellent, Good, Fair, Poor) based on total active motion of the injured finger. The higher the Tang score, the better functional outcome.

  Three months after Tendon repair

Study Arms (2)

Four strand repair group

EXPERIMENTAL

Participants in this group will undergo repair of Zone 2 flexor tendon injuries using the four-strand core suture tendon repair technique followed by standardized postoperative rehabilitation.

Procedure: Four strand Repair technique

Six strand repair group

EXPERIMENTAL

Participants in this group will undergo repair of Zone 2 flexor tendon injuries using the six-strand core suture tendon repair technique followed by standardized postoperative rehabilitation.

Procedure: Six Strand Repair Technique

Interventions

Four strand Repair technique PROCEDURE

Repair of Zone 2 flexor tendon injuries using a four-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation.

Four strand repair group

Six Strand Repair Technique PROCEDURE

Repair of Zone 2 flexor tendon injuries using a six-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation.

Six strand repair group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants.
• Age 18 to 50 years.
• Zone II flexor tendon injury of the hand.
• Presentation within one week of injury.
• Willingness to participate and provide informed consent.
• Ability to comply with the postoperative rehabilitation protocol.

You may not qualify if:

• Injuries that interfere with postoperative rehabilitation.
• Extensive soft tissue damage associated with the tendon injury.
• Previous tendon injury in the same digit or hand region.
• Previous surgery in the same affected area.
• Non-compliance or anticipated inability to comply with the postoperative rehabilitation protocol.
• Evidence of a psychological or personality disorder that may affect participation or outcome assessment.
• Systemic illness that may compromise wound or tendon healing (e.g., uncontrolled diabetes mellitus, connective tissue disorders, severe vascular disease).

Sponsors & Collaborators

• Allied Hospital Faisalabad: lead

Study Sites (1)

Allied Hospital, Faisalabad Medical University

Faisalabad, Punjab Province, 00000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident, Department of Plastic Surgery

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 4, 2026
• Study Start: January 27, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 26, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)